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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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28 January 2013 |
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Main ID: |
NCT01281904 |
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Date of registration:
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20/01/2011 |
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Primary sponsor: |
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Public title:
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Acupressure for Persistent Cancer Related Fatigue
AcuCrft |
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Scientific title:
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Acupressure for Persistent Cancer-Related Fatigue in Breast Cancer Survivors |
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Date of first enrolment:
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April 2011 |
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Target sample size:
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360 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01281904 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
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Countries of recruitment
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United States
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Contacts
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Name:
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Suzanna Zick |
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Address:
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Telephone:
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866-500-9228 |
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Email:
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fammed-szickstudy@med.umich.edu |
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Affiliation:
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Name:
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Suzanna M Zick |
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Address:
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Telephone:
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1-866-500-9228 |
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Email:
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fammed-szickstudy@med.umich.edu |
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Affiliation:
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Name:
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Suzanna M Zick, ND, MPH |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Michigan |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- 18 years of age or older
- Diagnosis of breast cancer
- Have completed all cancer related treatments (i.e. surgery, chemotherapy,
radiotherapy, immunotherapy, etc.) at least 1 year prior to enrollment except for
hormone therapy which must have been initiated at least three weeks prior to
enrollment
- Apparently cancer-free
- Able to self-administer acupressure
- Have a complaint of persistent, moderate to severe fatigue despite standard treatment
[defined as = 4 on the Brief Fatigue Inventory (BFI)]
- Able to maintain typical dietary (eating and drinking) patterns, especially the use
of caffeinated beverages throughout the study
- Willing to participate in an 11-week clinical trial that involves 5 study visits (not
including the screening visit, as well as weekly phone calls
Exclusion Criteria:
- Pregnant (per urine pregnancy test), wanting to become pregnant or Lactating
- Diagnosis of anemia or receiving treatment for it
- Have any comorbidities likely to cause significant fatigue (i.e., moderate to severe
heart failure, hypothyroidism, chronic fatigue syndrome) either currently or before
cancer diagnosis
- Have a diagnosis of depression, receiving active treatment for depression, or have
HADS score of =11
- Currently taking medication for insomnia
- Have an initiation, cessation or change of dose (up to three weeks prior to the
study's start) of any chronic medications or dietary supplements or any planned
change of chronic medications or dietary supplements during the study
- Had acupuncture or acupressure within the last 6 months
Age minimum:
18 Years
Age maximum:
75 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Breast Cancer
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Chronic Fatigue
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Sleepiness
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Intervention(s)
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Behavioral: Relaxation Acupressure
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Behavioral: Stimulating Acupressure
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Primary Outcome(s)
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The effect of 6-weeks of Relaxation Acupressure compared to a regime of Stimulating Acupressure or standard of care on fatigue.
[Time Frame: 12 weeks]
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Secondary Outcome(s)
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Onset and duration of acupressure effect.
[Time Frame: 12 weeks]
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The effect of 6-weeks of Relaxation Acupressure compared to a regime of Stimulating Acupressure or standard of care on sleep quality
[Time Frame: 12 weeks]
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Secondary ID(s)
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CA151445
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R01CA151445
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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